Abstract

Background

Clinical trials throughout the world must be evaluated by research ethics committees.
No one has yet attempted to clearly quantify at the national level the activity of
ethics committees and describe the characteristics of the protocols submitted. The
objectives of this study were to describe 1) the workload and the activity of Research
Ethics Committees in France, and 2) the characteristics of protocols approved on a
nation-wide basis.

Methods

Retrospective cohort of 976 protocols approved by a representative sample of 25/48
of French Research Ethics Committees in 1994. Protocols characteristics (design, study
size, investigator), number of revisions requested by the ethics committee before
approval, time to approval and number of amendments after approval were collected
for each protocol by trained research assistant using the committee's files and archives.

Results

Thirty-one percent of protocols were approved with no modifications requested in 16
days (95% CI: 14–17). The number of revisions requested by the committee, and amendments
submitted by the investigator was on average respectively 39 (95% CI: 25–53) and 37
(95% CI: 27–46), per committee and per year. When revisions were requested, the main
reasons were related to information to the patient (28%) and consent modalities (18%).
Drugs were the object of research in 68% of the protocols examined. The majority of
the research was national (80%) with a predominance of single-centre studies. Workload
per protocol has been estimated at twelve and half hours on average for administrative
support and at eleven and half hours for expertise.

Conclusion

The estimated workload justifies specific and independent administrative and financial
support for Research Ethics Committees.